The Registry Study of Genetic Alterations of Oropharyngeal Cancer in Taiwan

• ClinicalTrials.gov Identifier: NCT05522881
• Recruitment Status: Recruiting
• First Posted: August 31, 2022
• Last Update Posted: February 8, 2023
• Sponsor: National Health Research Institutes, Taiwan
• Collaborators: National Taiwan University Hospital; Taipei Veterans General Hospital, Taiwan; China Medical University Hospital; Taichung Veterans General Hospital; National Cheng-Kung University Hospital; Kaohsiung Veterans General Hospital.
• Information provided by (Responsible Party): National Health Research Institutes, Taiwan

Study Description

Brief Summary:

We will use the next-generation sequencing (NGS) technology to identify genomic alterations of Taiwanese HPV positive and negative oropharyngeal squamous cell carcinoma (OPSCC) for novel biomarker development and the study design of potential clinical trials or translational research.

Condition or disease
Oropharyngeal Squamous Cell Carcinoma

Detailed Description:

In the past decade, next-generation sequencing (NGS) technology has enabled cancer genome sequencing in screening and searching for new cancer genes in an efficient manner. This massive sequencing technique not only help to identify new altered genes for novel biomarker development, but also reveal gene alterations sensitive or resistant to specific therapies. Because the difference of genomic profiling between Taiwanese HPV positive and negative OPSCC is not clear yet, we propose this multi-center research project to address this issue. In this study, we will collect tumor tissues and clinical information from patients with OPSCC and create a platform for data storage and sharing.

Study Design

• Study Type: Observational
• Estimated Enrollment: 300 participants
• Observational Model: Case-Control
• Time Perspective: Other
• Official Title: The Registry Study of Genetic Alterations of Oropharyngeal Cancer in Taiwan
• Actual Study Start Date: November 25, 2022
• Estimated Primary Completion Date: December 30, 2029
• Estimated Study Completion Date: December 30, 2029

Groups and Cohorts

Group/Cohort
HPV positive-Post treatment; The subject has received any anti-cancer treatment with pathological report of squamous cell carcinoma of oropharynx (soft palate, tonsil, base of tongue, pharyngeal wall, uvula or vallecula) and positive p16 immunohistochemical staining.
HPV negative-Post treatment; The subject has received any anti-cancer treatment with pathological report of squamous cell carcinoma of oropharynx (soft palate, tonsil, base of tongue, pharyngeal wall, uvula or vallecula) and negative p16 immunohistochemical staining.
HPV positive-Treatment-naïve; The subject has received no anti-cancer treatment with pathological report of squamous cell carcinoma of oropharynx (soft palate, tonsil, base of tongue, pharyngeal wall, uvula or vallecula) and positive p16 immunohistochemical staining.
HPV negative-Treatment-naïve; The subject has received no anti-cancer treatment with pathological report of squamous cell carcinoma of oropharynx (soft palate, tonsil, base of tongue, pharyngeal wall, uvula or vallecula) and negative p16 immunohistochemical staining.

Outcome Measures

Primary Outcome Measures :

1. To enroll a total of 300 patients with OPSCC who fit the criteria of this study in the enrolled period [ Time Frame: 5 years of proposed observation period ]
   To enroll a total of 300 patients with OPSCC who fit the criteria of this study in the enrolled period

Secondary Outcome Measures :

1. To perform next generation sequencing analysis of OPSCC tumor tissues [ Time Frame: 5 years of proposed observation period ]
   To perform next generation sequencing analysis of OPSCC tumor tissues
2. Collect clinical data of OPSCC [ Time Frame: 5 years of proposed observation period ]
   To correlate with the clinical characteristics and treatment outcomes of patients with the genetic profile in Taiwan.
3. To compare the difference of the genetic and molecular profiles among patients with HPV positive and negative OPSCC [ Time Frame: 5 years of proposed observation period ]
   To compare the difference of the genetic and molecular profiles among patients with HPV positive and negative OPSCC
4. To compare the difference of genetic and molecular profiles between early (stage I and II) and advanced stage (stage III and IV) of HPV positive OPSCC [ Time Frame: 5 years of proposed observation period ]
   To compare the difference of genetic and molecular profiles between early (stage I and II) and advanced stage (stage III and IV) of HPV positive OPSCC

Biospecimen Retention:   Samples With DNA

One H&E-stained slide, and at least 10 unstained tissue on non-coated slides (5 um thickness) for cancer panel-based NGS analysis.20 unstained tissue on non-coated slides (4 um thickness) will be required for HPV genotyping testing.

20 ml Cell-Free DNA blood will be collected from the subjects within two weeks of the study registration. Of the treatment-naïve group, 20 ml blood specimens will be additionally collected at week 4 and 8 after the curative therapy is completed then every 6 months until the study withdrawal or tumor recurrence. For all subjects receiving the curative therapy, 20 ml of blood specimen will be collected when tumor recurrence is diagnosed at follow-up after the study registration.

Eligibility Criteria

• Ages Eligible for Study: 20 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

To enroll a total of 300 patients with OPSCC.

Criteria

Inclusion Criteria:

1. Ages 20 and above
2. Pathological reported as squamous cell carcinoma of oropharynx (soft palate, tonsil, base of tongue, pharyngeal wall, uvula or vallecula)
3. Available p16 immunohistochemical staining status
4. Willingness to provide archival or newly obtained tumor tissues for current study proposal
5. Life expectancy more than 3 months
6. Patients fully understand the protocol with the willingness to have regular follow-up

Exclusion criteria

1. Inability to cooperate by providing a complete medical history
2. No available tumor tissues for genetic testing
3. Undesirable compliance
4. Having a known additional malignancy that is progressing or has required active treatment within the past 3 years. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., cervical carcinoma in situ) that have undergone potentially curative therapy are not excluded

Contacts and Locations

Contacts

Contact: Shang-Hung Chen, MD.PhD; 886 (06) 7000123 ext 65113; bryanchen@nhri.edu.tw

Contact: Pei-Jen Lou, MD, PhD; 886 (02) 23123456 ext 65224; pjlou@ntu.edu.tw

Locations

Taiwan

Kaohsiung Veterans General Hospital; Recruiting

Kaohsiung, Taiwan

Contact: Bor-Hwang KANG, M.D. +88673422121 ext 74600 bhkang@vghks.gov.tw

Principal Investigator: Bor-Hwang KANG, M.D.

Sub-Investigator: Ching-Chih Lee, M.D.

China Medical University Hospital; Recruiting

Taichung, Taiwan, 400

Contact: Chun-Hung Hua Bai, MD 886-4-22052121 ext 2901 entmanhua@gmail.com

Principal Investigator: Chun-Hung Hua, MD

Sub-Investigator: Ching-Yun Hsieh, MD

Sub-Investigator: Ming-Yu Lien, MD

Sub-Investigator: Hsiu-San Hsu, MD

Sub-Investigator: Chun-Yu Lai, MD

Taichung Veterans General Hospital; Recruiting

Taichung, Taiwan

Contact: Chen-Chi Wang, M.D. +886423592525 ext 83601 entccwang@msn.com

Principal Investigator: Chen-Chi Wang, M.D.

Sub-Investigator: Yi-Chun Liu, M.D.

National Cheng Kung University Hospital; Recruiting

Tainan, Taiwan

Contact: Jenn-Ren Hsiao, MD,PhD hsiaojr@mail.ncku.edu.tw

Principal Investigator: Jenn-Ren Hsiao, MD,PhD

Sub-Investigator: Chun-Yen Ou, MD

Sub-Investigator: Wei-Ting Lee, MD

Sub-Investigator: Chan-Chi Chang, MD

Sub-Investigator: Yuan-Hua Wu, MD

Sub-Investigator: Shang-Yin Wu, M.D.

Sub-Investigator: Shang-Hung Chen, MD,PhD

Sub-Investigator: Hui-Jen Tsai, MD,PhD

Sub-Investigator: Yung-Yeh Su, MD

Sub-Investigator: Kwang-Yu Chang, MD,PhD

Sub-Investigator: Chia-Jui Yen, MD,PhD

Pei-Jen Alex Lou; Recruiting

Taipei, Taiwan

Contact: Pei-Jen Lou, MD, PhD +886223123456 pjlou@ntu.edu.tw

Principal Investigator: Pei-Jen A Lou, MD, PhD

Sub-Investigator: Yang Tsung-Lin, MD

Sub-Investigator: Cheng-Ping Wang, MD

Sub-Investigator: Tseng-Cheng Chen, MD

Sub-Investigator: Chun-Nan Chen, MD

Sub-Investigator: Yung-Ming Jeng, MD

Taipei Veterans General Hospital; Recruiting

Taipei, Taiwan

Contact: Pen-Yuan Chu, MD +88622875-7337 ext 102 pychu@vghtpe.gov.tw

Principal Investigator: Pen-Yuan Chu, MD

Sub-Investigator: Muh-Hwa Yang, MD,Ph.D.

Sub-Investigator: Shyh-Kuan Tai, MD

Sub-Investigator: Tsung-Lun Lee, MD

Sub-Investigator: Ying-Ju Kuo, MD

Sponsors and Collaborators

National Health Research Institutes, Taiwan

National Taiwan University Hospital

Taipei Veterans General Hospital, Taiwan

China Medical University Hospital

Taichung Veterans General Hospital

National Cheng-Kung University Hospital

Kaohsiung Veterans General Hospital.

Investigators

• Principal Investigator: Pei-Jen Lou, MD, PhD; National Taiwan University Hospital
• Principal Investigator: Shang-Hung Chen, MD, PhD; National Health Research Institutes, Taiwan

More Information

• Responsible Party: National Health Research Institutes, Taiwan
• ClinicalTrials.gov Identifier: NCT05522881
• Other Study ID Numbers: T1322
• First Posted: August 31, 2022
• Last Update Posted: February 8, 2023
• Last Verified: August 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Health Research Institutes, Taiwan:

human papillomavirus; oropharyngeal squamous cell carcinoma; next-generation sequencing; precision medicine

Additional relevant MeSH terms:

Carcinoma, Squamous Cell; Oropharyngeal Neoplasms; Squamous Cell Carcinoma of Head and Neck; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases